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临床试验/NCT01681550
NCT01681550Unknown不适用

Effect of Incretin-based Therapy Combined With Insulin on HbA1c, Hypoglycemia and Chronic Diabetic Complications in Type 2 Diabetic Patients

Nagaoka Red Cross Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Death

研究概览

简要总结

The use of dipeptidyl-peptidase 4 (DPP-4) inhibitors and glucagon like peptide 1 (GLP1) analogues for the treatment of diabetic mellitus (DM) type 2 is growing (1,2). Currently, some of these agents have been approved in combination with insulin. The potential for combined use with insulin has garnered increasing attention due to reduce side effects associated with insulin therapy and improve glycemic control. Some investigators reported that GLP-1 analogue combined with insulin reduces HbA1c and weight with low risk of hypoglycemia and high treatment satisfaction (3). However, their duration of treatment was short time with less than a mean of 3.0 years and the alterations of chronic diabetic complications by combination with incretin-based and insulin therapies are not known.

We evaluated the long effects of adding incretin-based therapy (DPP-4 inhibitors or GLP-1 analogues) to insulin therapy on glycated hemoglobin (HbA1c) as glycemic control, body mass index (BMI), blood pressure (BP), insulin dosage, frequency of hypoglycemia, and chronic diabetic complications for 5 years-treatments.

详细描述

Patients were treated with diet, exercise, and/or oral conventional pharmacotherapy combined with insulin. Oral conventional pharmacotherapy consisted of α-glycosidase inhibitors (α-GI), sulfonylurea (SU), biguanide (BG), thiazolidinedione (TZD), or combinations of these agents. Insulin therapy consisted of subcutaneous injections of long-acting insulin analogues prior to sleep and bolus subcutaneous injections of rapid-acting insulin analogues in multiple daily injections, or subcutaneous injections of mixed insulin analogues twice a day. In spite of the treatments, when the physician in charge judged that their values of HbA1c were inappropriate, the physician added the pharmacotherapy combined the insulin to incretin-based therapy. 2.3.2. For ethical reasons, patients were treated with various anti-hypertensive, anti-diabetic, anti-dyslipidemia and/or anti-hypercoagulation agents during the course of the study by the patients' own doctors as a part of continuing standard medical care. As to the drugs that have been used for the treatment of other disorders and its complication since the time before the study, the content should not be changed during the study in principle unless the complication is cured. If any new complication occurs during the study period, an appropriate treatment is given by the judgment of investigator.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • After a detailed baseline examination, 500 Japanese subjects with type 2 diabetes were followed up for all-cause mortality and morbidity. All participants visited our clinic regularly. All patients were fully informed about the purposes and procedures for the study and provided oral consent at enrolment.

排除标准

  • Patients participating in other clinical study. Other than the above, patients judged inappropriate as the subjects of this study by the investigator.

研究组 & 干预措施

Incretin theapy combined with insulin

Other

干预措施: Incretin-based therapy (Drug)

结局指标

主要结局

Death

时间窗: Duration varied between individual patients and was as the period of time after treatment with incretin-based therapy combined with insulin.

The cause of death was determined by attending doctor or was assessed by interviewing the family.

次要结局

  • HbA1c(Average time requires 5 years)
  • BMI(Average time requires 5 years)
  • Blood pressure(Average time requires 5 years)
  • Insulin dose(Average time requires 5 years)
  • Hypoglycemia(Average time requires 5 years)
  • Microvascular complications including renal anemia(Average time requires 5 years)
  • Macrovasular complications(Average time requires 5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kyuzi Kamoi

MD

Nagaoka Red Cross Hospital

研究点 (1)

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